ES2 SPINAL SYSTEM 482802880Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327002546), received between Sep 13, 2016 and Apr 17, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2025Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AN ES2 INTEGRATED BLADE SCREW FRACTURED POST-OPERATIVELY. NO ADVERSE CONSEQUENCES WERE REPORTED. THE FRACTURED SCREW WAS OBSERVED IN A REVISION SURGERY (ADDRESSED IN 0009617544-2025-00048) APPROXIMATELY 8.5 YEARS POST-OPERATIVELY. THE SCREW TULIP WAS EXPLANTED, HOWEVER THE SCREW SHANK REMAINS IMPLANTED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21857938 ↗
• InjuryAug 24, 2021Migration; Migration

  IT WAS REPORTED THAT ON CT IMMEDIATELY AFTER SURGERY, SHOWED THAT THE SCREW BLOCKER OF THE LEFT S2 WAS COMING LOOSE. THE PATIENT WAS TAKEN BACK INTO THE SURGICAL SUITE AND ANESTHESIA WAS ADDED, THE WOUND WAS REOPENED, AND THE SCREW AND BLOCKER WERE REPLACED WITH NEW ONES. THIS LED TO A 20-30 MINUTE DELAY. THIS REPORT WILL COVER THE BLADE SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12362986 ↗
• MalfunctionApr 12, 2019Material Separation; Unintended Movement; Unintended Movement

  ON (B)(6) 2019 EXTRACTION SURGERY WAS PERFORMED; THE PHYSICIAN INDICATED, "THE BONE OF THE PATIENT WAS HEALING." DURING EXTRACTION THE PHYSICIAN NOTED THAT THE HEAD OF THE SCREW INSERTED IN THE ILIAC BONE WAS DISSOCIATED FROM THE BODY OF THE SCREW. THE PHYSICIAN INDICATED THIS OCCURRED POST-OPERATIVELY, WHILST THE DEVICE WAS IMPLANTED. THE DISENGAGED SCREW WAS REMOVED AND SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8511690 ↗
• MalfunctionSep 13, 2016Mechanical Problem; Failure to Align; Device Operates Differently Than Expected; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, TH9 - S2AI WERE FIXED. L2 AND L3 PSO WAS PERFORMED. DURING FINAL CONFIRMATION WITH X-RAY, THE DEVIATION OF RIGHT S2AI SCREW HEAD WAS FOUND. THE SURGEON EXCHANGE THE SCREW AND FINISHED THE SURGERY.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 5945711 ↗